To study whether flavoprotein imaging can be used to diagnose painful polyneuropathy, we first need to investigate whether a reproducible and validated flavoprotein signal can be obtained on the second fingertip of healthy subjects.
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-size and time course of the flavoprotein response
-linearity of the electrical stimulation with the flavoprotein response
-blockade of the flavoprotein response by lidocaine/prilocaine cream and
capsaicin 8% patches
Secondary outcome
not applicable
Background summary
Painful polyneuropathy is a common condition that is difficult to diagnose and
to treat and which has a negative impact on quality of life. Painful
polyneuropathy, is caused by degeneration of small nerve fibers. With current
techniques, the diagnosis of small fiber neuropathy is not set reliably.
Flavoprotein is an optical method suitable to reliably measure activation by
nerve nerve fiber endings in the spinal cord. Because the epidermis also
contains a high density of (small) nerve fiber endings, we hypothesize that
flavoprotein imaging is suitable for diagnosing small fiber neuropathy.
Study objective
To study whether flavoprotein imaging can be used to diagnose painful
polyneuropathy, we first need to investigate whether a reproducible and
validated flavoprotein signal can be obtained on the second fingertip of
healthy subjects.
Study design
-to examine whether there is a temporal relationship between administration of
an electrical stimulus by means of finger electrodes, and an optical
(flavoprotein) signal on the fingertip of subjects
-to examine whether there is a linear relationship between the strength of the
applied electrical signal, and the size of the optical (flavoprotein) signal
-to study whether the signal is specific for the flavoprotein wavelength, by
means of the exchange of the filter settings of the camera
-to study whether the optical (flavoprotein) signal can be blocked by means of
administration of lidocaine / prilocaine cream on the fingertip
-to study whether the optical (flavoprotein) signal can be blocked by means of
administration of a capsaicin 8% patch to the fingertip
Intervention
intervention with lidocaine / prilocaine cream and capsaicin 8% patches is not
the purpose of the study, but serves as a negative control.
Study burden and risks
-time: 45 minutes per person
-discomfort: brief painful electrical stimulation, approximately 3 hour
numbness of the index fingertip, about 3 days hypersensitivity to pressure and
temperature of the middle fingertip
-risk: no
's Gravendijkwal 230 kamer Hs-609
Rotterdam 3015 CE
NL
's Gravendijkwal 230 kamer Hs-609
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
healthy volunteers
Exclusion criteria
-younger than 18 years
-pre-existing neuropathy
-previous allergic reaction to local anaesthetics
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-002561-29-NL |
| CCMO | NL49568.078.14 |